Browse Device Recalls

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 39,969 FDA device recalls.

DateProductReasonClassFirm
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 API3200MD Mass Spectrometer, Part Number 4466230 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LE-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-L-100. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Genera... Ultrasound devices were not authorized, cleared, or approved by FDA, and thus their performance c... Class II RoyalVibe Health Ltd.
Aug 30, 2023 4500MD Triple Quad Mass Spectrometer, Part Number 5032522 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 Citrine Triple Quad Mass Spectrometer, Part Number 5063684 In rare occasions, the combination of a leak of a highly flammable solvent at the ion source prob... Class II AB Sciex, LLC
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LE-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 29, 2023 PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product... Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue,... Class II Limacorporate S.p.A
Aug 29, 2023 Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to re... Device is breaking while in use, potential for patients to require a revision surgery. Class II Flower Orthopedics Corporation
Aug 29, 2023 Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... Unintended movement of bed wheels Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Aug 29, 2023 Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000... Unintended movement of bed wheels Class II ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Aug 29, 2023 REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 ... There is the potential that the safety shield may not properly engage on IV catheters. The needle... Class II Becton Dickinson Infusion Therapy Systems Inc.
Aug 29, 2023 Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quan... Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual ki... Class II CooperSurgical, Inc.
Aug 25, 2023 Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807 One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade. Class II Beaver Visitec International, Inc.
Aug 25, 2023 Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 25, 2023 Detector H. Pylori, Catalog Number IHP-30 Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the ... Class II Immunostics, Inc.
Aug 25, 2023 Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 4535615444... Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of fun... Class I Philips Respironics, Inc.
Aug 25, 2023 Multichem P, Part Code 08P90-10 Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... Class II TECHNO-PATH MANUFACTURING LTD.
Aug 24, 2023 AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 Peripheral coil system detachable has a potential of unsealed pouch packaging. Class II MICROVENTION INC.
Aug 24, 2023 Various Medical Products stored on pallets, including but not limited to band... Various medical devices potentially exposed to rodent and rodent activity. In addition, medical d... Class II Inmar Supply Chain Solutions, LLC
Aug 24, 2023 Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-... Full screen error message may occur on patient monitors with affected hardware version, either du... Class II Remote Diagnostic Technologies Ltd.
Aug 23, 2023 MINISCAV (tm) Vacuum Pump Inadequate documentation of acceptance activity Class II R A Medical Services
Aug 23, 2023 LFS Flat screen arm system with surgical lamp for Models Aurora series, Auror... The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... Class II DKK Dai-Ichi Shomei Co., Ltd.
Aug 23, 2023 Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462 Expired Product distributed Class II Stryker Corporation
Aug 23, 2023 LFS Flat screen support arm systems without surgical lamp for models Aurora s... The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... Class II DKK Dai-Ichi Shomei Co., Ltd.
Aug 22, 2023 EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 Knee insert and acetabular system parts were swapped within inner pack prior to the product being... Class II Encore Medical, LP
Aug 22, 2023 EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H Knee insert and acetabular system parts were swapped within inner pack prior to the product being... Class II Encore Medical, LP
Aug 22, 2023 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Roto... Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_... Class II Qiagen GmbH
Aug 22, 2023 Puritan Bennett Cuff Pressure Manager, REF: 180-03 Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes t... Class II Covidien
Aug 22, 2023 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qu... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designe... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 22, 2023 Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implan... Class II Covidien LP
Aug 22, 2023 Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P... The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) b... Class II Smiths Medical ASD Inc.
Aug 22, 2023 REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, ... Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5... Class II Encore Medical, LP
Aug 22, 2023 Apellis Injection Kit 29g Injection Needle -single use intended to inject flu... 19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred charact... Class II Apellis Pharmaceuticals, Inc.
Aug 22, 2023 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualif... Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rap... Class II 3M Company - Health Care Business
Aug 18, 2023 Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC866... The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the pro... Class II North Coast Medical Inc
Aug 18, 2023 OPMI LUMERA 300, REF 6137 Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, whic... Class II Carl Zeiss Suzhou Co., Ltd.
Aug 18, 2023 Constellation Vision System, REF: 8065751150 Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could ... Class II Alcon Research, LLC
Aug 18, 2023 BD Pyxis MedBank MedPass Software, REF: 139088-01 After dispensing a timed dose medication for a patient, the automated dispensing cabinet software... Class II CareFusion 303, Inc.
Aug 17, 2023 SOZO Bilateral Arm L-Dex Software Bilateral L-Dex assessment software does not have the same level of sensitivity to help detect ea... Class II Impedimed Limited
Aug 17, 2023 exoplan version 3.1 Rijeka Software -A medical software, intended to support ... A software library filtering error has been discovered which occurs when users are using the Step... Class II Exocad GmbH
Aug 17, 2023 Patient Information Center iX with Software Version Number 4.x in the followi... Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driv... Class II Philips North America Llc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.